510(k) K091323 ยท GEX Powered Laser Surgical Instrument
MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200)
| Applicant | Intermedic Arfran, SA, Pleasanton CA, US |
| Decision | Substantially Equivalent, Jun 4, 2009 |
| Received | May 5, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091323
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.